Tight Glycemic Control in Critical Care Patients

Tight Glycemic Control in Patients Hospitalized in a Medical-Surgery Intensive Care Unit: A Randomized Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00096421

Enrollment

504

Registered

2004-11-10

Start date

2003-07-31

Completion date

2006-09-30

Last updated

2006-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Hyperglycemia, Insulin Resistance

Keywords

Critical illness, Critical care, Hyperglycemia, Intensive care, Intensive Care Units, Insulin resistance, Intensive insulin therapy, Conventional insulin therapy

Brief summary

The purpose of this study is to evaluate the impact of tight control of serum glucose levels with an intensive insulin treatment in patients hospitalized in an intensive care unit with medical and surgical patients.

Detailed description

Reduction of morbidity-mortality in critical care patients with tight glycemic control had been proven in surgical patients only. Study Hypothesis: In critical care patients, medical or surgical, a glucose serum level between 80 - 110 mg/dL means a lower mortality than patients with glucose levels of more than 110 mg/dL.

Interventions

BEHAVIORALTight control of blood glucose levels

BEHAVIORALConventional control of glucose levels

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

* 15 years of age or older, * Probability of staying in critical care for more than 48 hours, * Agreement with the informed consent.

Exclusion criteria

* Pregnancy, * Participating in other trials, * Diabetic keto-acidosis or diabetic hyperosmolar state, * Moribund * Do-not-resuscitate orders, * Reentry to the critical care unit of the same patient.

Design outcomes

Primary

Measure	Time frame
Mortality in the next 28 days	—

Secondary

Measure	Time frame
Mortality overall in-hospital	—
Mortality among patients who remained in the intensive care unit for more than five days	—
Infections incidence in the critical care unit: nosocomial pneumonia, urinary tract infection and catheter related infection	—
Length of stay in the unit	—
Mortality during intensive care	—
Acute renal failure requiring dialysis or hemofiltration	—
The median number of red-cell transfusions	—
SOFA score	—
Critical-illness polyneuropathy	—
Days of ventilatory support	—

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026